Page:United States Statutes at Large Volume 102 Part 4.djvu/1012

 102 STAT. 3982

21 USC 360b. 21 USC 360b.

21 USC 360b

PUBLIC LAW 100-670—NOV. 16, 1988 "(G) the application failed to contain the patent information prescribed by subsection (b)(1);". (3) The second sentence of section 512(d)(1) is amended by striking out "(H)" and inserting in lieu thereof "(G)". (4) The first sentence of section 512(e)(1) is amended by redesignating subparagraphs (D) and (E) as subparagraphs (E) and (F), respectively, and by inserting after subparagraph (C) the following: "(D) the patent information prescribed by subsection (c)(3) was not filed within 30 days after the receipt of written notice from the Secretary specifying the failure to file such information;".

SEC. 103. REGULATIONS.

(a) GENERAL RULE.—The Secretary of Health and Human Services shall promulgate, in accordance with the notice and comment requirements of section 553 of title 5, United States Code, such regulations as may be necessary for the administration of section 512 of the Federal Food, Drug, and Cosmetic Act, as amended by sections 101 through 103 of this title, within one year of the date of enactment of this Act. O> TRANSITION.—During the period beginning 60 days after the t) date of enactment of this Act and ending on the date regulations promulgated under subsection (a) take effect, abbreviated new animal drug applications may be submitted in accordance with the provisions of section 314.55 and part 320 of title 21 of the Code of Federal Regulations and shall be considered as suitable for any drug which has been approved for safety and effectiveness under section 512(c) of the Federal Food, Drug, and Cosmetic Act before the date of enactment of this Act. If any such provision of section 314.55 or part 320 is inconsistent with the requirements of section 512 of the Federal Food, Drug, and Cosmetic Act (as amended by this title), the Secretary shall consider the application under the applicable requirements of section 512 (as so amended). SEC. 104. SAFETY AND EFFECTIVENESS DATA.

Public information.

Section 512 (as amended by section lOlOt)) of this title) is amended by adding at the end the following: "(p)(l) Safety and effectiveness data and information which has been Submitted in an application filed under subsection (b)(1) for a drug and which has not previously been disclosed to the public shall be made available to the public, upon request, unless extraordinary circumstances are shown— "(A) if no work is being or will be undertaken to have the application approved, (B) if the Secretary has determined that the application is not approvable and all legal appeals have been exhausted, "(C) if approval of the application under subsection (c) is withdrawn and all legal appeals have been exhausted, "(D) if the Secretary has determined that such drug is not a new drug, or "(E) upon the effective date of the approval of the first application filed under subsection (b)(2) which refers to such drug or upon the date upon which the approval of an application filed under subsection (b)(2) which refers to such drug could be made effective if such an application had been filed. "(2) Any request for data and information pursuant to paragraph (1) shall include a verified statement by the person making the

�